[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78727-78731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-31101]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0286; FRL-9904-30]


Copper Sulfate Pentahydrate; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of copper sulfate pentahydrate when applied 
to all food contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment at a maximum level in the end 
use concentration of 80 parts per million (ppm). Toxcel on behalf of 
OhSo Clean, Inc., submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting establishment of an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of copper sulfate pentahydrate.

DATES: This regulation is effective December 27, 2013. Objections and 
requests for hearings must be received on or before February 25, 2014, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0286, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave., NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review

[[Page 78728]]

the visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0286 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
February 25, 2014. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0286, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 2E8116) by 
Toxcel, P.O. Box 363, 7140 Heritage Village Plaza, Gainesville, VA 
20156, on behalf of OhSo Clean, Inc., 315 Pacific Ave., San Francisco, 
CA 94111. The petition requested that 40 CFR 180.940 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of copper sulfate pentahydrate (Chemical Abstracts Service 
Registry Number (CAS Reg. No.) 7758-99-8) when used as an inert 
ingredient (emulsion stabilizer) in antimicrobial pesticide 
formulations (food contact surface sanitizing solutions) not to exceed 
80 ppm. That document referenced a summary of the petition prepared by 
Toxcel LLC., 7140 Heritage Village Plaza, Gainesville, VA 20155, the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply non-
toxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. To determine the risks from aggregate exposure to pesticide 
inert ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the

[[Page 78729]]

requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for copper sulfate pentahydrate 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with copper 
sulfate pentahydrate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by copper sulfate pentahydrate, as well 
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies, are 
discussed in the final rule published in the Federal Register of August 
11, 2006 (71 FR 46106) (FRL-8085-3).
    Copper is ubiquitous in nature and is a necessary nutritional 
element for both animals (including humans) and plants. Copper is found 
naturally in the food we eat including fruits, vegetables, meats, and 
seafood. It is found in the water we drink, the air we breathe and in 
our bodies themselves. Some of the environmental copper is due to 
direct modification of the environment by humans such as mining and 
smelting of the natural ore. It is one of the elements found essential 
to life. The National Academy of Science establishes recommended daily 
allowances (RDAs) of vitamins and minerals for the diet. The RDA for 
copper ranges from approximately 400 micrograms per day ([micro]g/d) in 
young children to 900 [micro]g/d in adults. Additionally, over the 
counter dietary supplements containing copper at level ranging from 
0.33 milligram (mg) to 3 mg are available for individuals with low 
levels of copper. The copper ion is present in the adult human body 
with nearly two-thirds of the body copper content located in the 
skeleton and muscle. The liver is the primary organ for the maintenance 
of plasma copper concentrations.
    The 2006 Reregistration Eligibility Decision for copper compounds 
reviewed and summarized all toxicity studies submitted for copper and 
has determined that the toxicological database is sufficient to assess 
the hazard from pesticides containing copper. Copper generally has 
moderate to low acute toxicity based on acute oral, dermal, and 
inhalation studies in animals. However, copper sulfate pentahydrate 
specifically has a been classified as moderate for acute oral toxicity, 
low for acute dermal toxicity and dermal irritation, and high for 
primary eye irritation. All effects resulting from acute exposure to 
copper-containing pesticides are due to acute body responses to 
minimize excessive absorption or exposure to copper. Current available 
data in animals do not show any evidence of upper limit toxicity level 
that warrant determining acute toxicity endpoints.
    Based on available data summarized in the 2006 Reregistration 
Eligibility Decision for Coppers, there is no evidence of any dietary, 
oral, and dermal or inhalation adverse effects warranting quantitative 
assessment of sub-chronic or chronic risk. Available short-term feeding 
studies with rats and mice indicate decreased food and water intake 
with increasing oral concentrations of copper. Irritation of the 
stomach was seen at higher copper concentrations. Longer-term feeding 
studies indicate decreased feed intake with reductions in body weight 
gains, and increased copper concentration of the liver. Available 
reproductive and developmental studies by the oral route of exposure 
generally indicate that the main concern in animals for reproductive 
and teratogenic effects of copper has usually been associated with the 
deficiency rather than the excess of copper.
    Oral ingestion of excessive amounts of the copper ion from 
pesticidal uses including the proposed use is unlikely. Copper 
compounds are irritating to the gastric mucosa. Ingestion of large 
amounts of copper results in prompt emesis. This protective reflex 
reduces the amount of copper ion available for absorption into the 
human body. Additionally, at high levels humans are also sensitive to 
the taste of copper. Because of this organoleptic property, oral 
ingestion would also serve to limit high doses.
    Only a small percentage of ingested copper is absorbed, and most of 
the absorbed copper is excreted. The human body appears to have 
efficient mechanisms in place to regulate total body copper. The copper 
ion occurs naturally in food and the metabolism of copper is well 
understood.
    Finally, sulfate has little toxic effect and is routinely used in 
medicine as a cathartic when combined with magnesium or sodium; the 
only adverse manifestations from this use being dehydration if water 
intake is concurrently limited.

B. Toxicological Points of Departure/Levels of Concern

    No endpoints of toxicological concern were identified for risk 
assessment purposes for copper sulfate pentahydrate. Copper sulfate 
pentahydrate readily hydrolyzes into the copper cation and the sulfate 
anion. Copper is a required essential nutritional element for both 
plants and animals. Indeed, current available data and literature 
studies indicate that there is a greater risk from the deficiency of 
copper intake than from excess intake. Copper also occurs naturally in 
a number of food items including fruits, meats, seafood, and 
vegetables. In humans, as part of the utilization of copper as an 
essential nutrient, there is an effective homeostatic mechanism that is 
involved in the dietary intake of copper and that protects humans from 
excess body copper. Given that copper is ubiquitous, is an essential 
nutrient, and is routinely consumed as part of the daily diet, exposure 
to copper as a result of the use of copper sulfate pentahydrate as a 
pesticide chemical would not be of toxicological concern. Further, the 
sulfate anion is also ubiquitous; it is the substrate in a number of 
normal human biosynthetic reactions. Following ingestion, sulfate is 
poorly absorbed via the gastrointestinal tract and is excreted in the 
urine. Other than a slight laxative effect at extremely high doses, 
sulfate has no known adverse toxic effects.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to copper sulfate pentahydrate, EPA considered exposure under 
the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from copper sulfate pentahydrate in food as 
follows:
    The main source of copper for infants, children, and adults, 
regardless of age, is the diet. Copper is typically present in mineral 
rich foods like chocolate, fruits (peaches and raisins), grains (wheat 
and rye), nuts (peanuts and pecans), and vegetables (potatoes and 
legumes (beans and peas)) in levels that range from 0.3 to 3.9 ppm. It 
is not likely that the approval of this petition

[[Page 78730]]

would significantly increase exposure over that of the existing levels 
of copper.
    2. Dietary exposure from drinking water. Copper is a natural 
element found in the earth's crust. As a result, most of the world's 
surface water and ground water that is used for drinking purposes 
contains copper. The actual amount varies from region to region, 
depending on how much is present in the earth, but in almost all cases 
the amount of copper in water is extremely low. Naturally occurring 
copper in drinking water is safe for human consumption, even in rare 
instances where it is at levels high enough to impart a metallic taste 
to the water. Residues of copper in drinking water are regulated under 
the Safe Drinking Water Act. A Maximum Contaminant Level Goal of 1.3 
ppm has been set by the Agency for copper. According to the National 
Research Council's Committee on Copper in Drinking Water, this level is 
``set at a concentration at which no known or expected adverse health 
effects occur and for which there is an adequate margin of safety.'' 
The Agency believes that this level of protection would not cause any 
potential health problems, i.e., stomach and intestinal distress, liver 
and kidney damage, and anemia. It is not likely that the approval of 
this petition would significantly increase exposure over that of the 
existing levels of copper.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., carpets; hard surface disinfection on walls, floors, 
and tables; swimming pools; and textiles (clothing and diapers)).
    Residential (oral, dermal, and inhalation) exposure to copper 
sulfate pentahydrate from its use as an inert ingredient in food-
contact surface sanitizing solutions for public eating places, dairy 
processing equipment, and food-processing equipment and utensils is 
possible. However, since there are no toxicological effects of concern 
identified in the available database, it is not necessary to conduct a 
quantitative assessment of residential (non-occupational) exposures.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found copper 
sulfate pentahydrate to share a common mechanism of toxicity with any 
other substances, and copper sulfate pentahydrate does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
copper sulfate pentahydrate does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's Web site 
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    FFDCA, as amended by the Food Quality Protection Act (FQPA), 
directs the Agency to use an additional 10X safety factor (SF), to 
account for potential pre- and postnatal toxicity and completeness of 
the data with respect to exposure and toxicity to infants and children. 
FQPA authorizes the Agency to modify the 10X FQPA SF only if reliable 
data demonstrate that the resulting level of exposure would be safe for 
infants and children. Since copper is an essential trace element, with 
copper deficiency more common in humans than toxicity from the excess, 
a quantitative assessment using safety factors was not conducted for 
potential human health exposure to copper sulfate pentahydrate. For the 
same reason the 10X FQPA SF was not retained.

E. Aggregate Risks and Determination of Safety

    Taking into consideration the information discussed on copper 
sulfate pentahydrate, EPA has determined that there is a reasonable 
certainty that no harm to any population subgroup, including infants 
and children, will result from aggregate exposure to copper sulfate 
pentahydrate under reasonable foreseeable circumstances. Therefore, the 
establishment of an exemption from tolerance under 40 CFR 180.940(a) 
for residues of copper sulfate pentahydrate when used as an inert 
ingredient in pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils at a limit of 80 ppm is safe under 
FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
copper sulfate pentahydrate in or on any food commodities. EPA is 
establishing a limitation on the amount of copper sulfate pentahydrate 
that may be used in pesticide formulations.
    The limitation is enforced through the pesticide registration 
process under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) (7 U.S.C. 136 et seq.). EPA will not register any pesticide for 
sale or distribution that contains greater than 80 ppm of copper 
sulfate pentahydrate in the pesticide formulation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for copper sulfate pentahydrate.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for copper sulfate pentahydrate 
(CAS Reg. No. 7758-99-8) when used in antimicrobial pesticide 
formulations applied to all food contact surfaces in public eating 
places, dairy-processing equipment, and food-processing equipment and 
utensils at a maximum level in the end use concentration of 80 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is

[[Page 78731]]

not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 20, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.940, alphabetically add the following inert ingredient 
to the table in paragraph (a) to read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
       Pesticide chemical          CAS reg. no.           Limits
------------------------------------------------------------------------
 
                              * * * * * * *
Copper sulfate pentahydrate....       7758-99-8   When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 80 ppm
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-31101 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P